NCT02393924
Completed
Not Applicable
UK - A Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
ConditionsBreast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 311
- Locations
- 29
- Primary Endpoint
- Percentage of Participants Receiving Each Unique Treatment Regimen Overall
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This disease registry is a prospective, multicenter non-interventional study designed to observe the different anticancer treatment regimens and their sequencing throughout the course of the disease in participants with unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) and to describe the clinical outcome for each treatment regimen measured as progression-free survival.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Initially diagnosed with HER2-positive unresectable LABC or mBC no more than 6 months prior to enrollment, although they can have received anti-cancer treatment during that time
- •Able and willing to provide written informed consent and to comply with the study protocol
Exclusion Criteria
- •There are no exclusion criteria for entry into this study
Outcomes
Primary Outcomes
Percentage of Participants Receiving Each Unique Treatment Regimen Overall
Time Frame: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Unique Treatment Regimen Sequence
Time Frame: Baseline up to approximately 8 years
Progression-Free Survival
Time Frame: From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years)
Tumor response will be evaluated by the Investigator according to site-specific medical practice. Study protocol does not specify any particular method of assessment.
Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy
Time Frame: Baseline up to approximately 8 years
Secondary Outcomes
- Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR)(From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years))
- Percentage of Participants by Reasons for Treatment Modification(Baseline up to approximately 8 years)
- Time to Treatment Failure(From the date of initiation of treatment to the date of treatment stopped or switched or death from any cause (up to approximately 8 years))
- Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)(Baseline up to approximately 8 years)
- Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score(Baseline up to approximately 8 years (assessed every 3 months))
- Work Productivity and Activity Impairment (WPAI) Questionnaire Score(Baseline up to approximately 8 years (assessed every 3 months))
- Percentage of Participants with CNS-only Disease Progression(From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years))
- Percentage of Participants with Oligometastatic Disease Categorized by Different Anti-Cancer Treatment Regimens(Baseline up to approximately 8 years)
- Duration of Response (DoR)(From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years))
- Overall Survival (OS)(From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years))
- Euro Quality of Life 5-Dimension Questionnaire (EQ-5D) Score(Baseline up to approximately 8 years (assessed every 3 months))
- Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country(Baseline up to approximately 8 years)
- Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens(Baseline up to approximately 8 years)
- Percentage of Participants With Central Nervous System (CNS) as First Site of Progression(From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years))
- Percentage of Participants Receiving Each Treatment Regimen Categorized by Participant Characteristics(Baseline up to approximately 8 years)
- Number of Treatment Regimens Received(Baseline up to approximately 8 years)
Study Sites (29)
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